DocQLace

Drug Labeling and Warnings

Drug Details [pdf]

DOCQLACE- docusate sodium capsule 
Lake Erie Medical DBA Quality Care Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DocQLace

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

• relieves occasional constipation (irregularity)  
• generally produces bowel movement in 12 to 72 hours

Warnings

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

• stomach pain  
• nausea  
• vomiting  
• noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.  
• you need to use a laxative for more than 1 week

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

doses may be taken as a single daily dose or in divided doses

• adults and children 12 years and over: take 1-3 softgels daily
• children 2 to under 12 years of age: take 1 softgel daily
• children under 2 years: ask a doctor

Other information

• each softgel contains: sodium 5 mg VERY LOW SODIUM  
• store at 15°-30°C (59°-86°F)  
• keep tightly closed
  

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special

Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811

R0  07/2011
015021CPR

DOCQLACE 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55700-300(NDC: 0603-0150)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED (Reddish)	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	SCU1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55700-300-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/22/2015	06/30/2019
2	NDC: 55700-300-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/22/2015	06/30/2019
3	NDC: 55700-300-00	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/22/2015	06/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	08/01/2011	06/30/2019

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	relabel(55700-300)

Revised: 7/2019

Document Id: f22397b4-32aa-4ffb-aa02-004b8352dd18

34390-5

Set id: e03e5b5f-c317-4cb6-bb4f-830e8202a4da

Version: 2

Effective Time: 20190710

 

Lake Er